Publications Archive - Page 153 of 293 - Wiggin and Dana LLP — Attorneys At Law (2024)

December 10, 2014 Advisory

Michelle Wilcox DeBarge, Jody Erdfarb, Michael Menapace

As the number of data breaches and federal and state enforcement actions for privacy and security violations reach new heights, Connecticut's highest court has added fuel to the fire in a decision that paves the way for individuals to use Health Information Portability and Accountability Act (HIPAA) violations as a basis for state negligence claims.

HIPAA does not provide a private right of action for violations. Only the federal or state government can seek sanctions, including fines, for HIPAA noncompliance. The absence of a private right of action under HIPAA has largely impeded private lawsuits that cite HIPAA violations as the basis for a negligence claim. Yet, in Byrne v. Avery Center for Obstetrics and Gynecology, P.C., 2014 WL 5507439 (Conn. Nov. 11, 2014), the Connecticut Supreme Court ruled that a plaintiff may use HIPAA to establish the standard of care in negligence cases.

Byrne was a patient of the Avery Center for Obstetrics and Gynecology, P.C. The putative father of Byrne's child served the Avery Center with a subpoena for Byrne's medical records in connection with a paternity action filed against Byrne. The Avery Center mailed a copy of Byrne's records to the court without filing a motion to quash the subpoena, appearing in court, or notifying Byrne. The putative father apparently accessed Byrne's medical records in the court file. Byrne sued the Avery Center for failure to use reasonable care in protecting her medical information, including disclosing it in violation of HIPAA.[1] The trial court dismissed these claims ruling that since HIPAA does not allow a private right of action, Byrne could not assert negligence claims against the Avery Center based on HIPAA noncompliance.

What the Connecticut Supreme Court Said

The Connecticut Supreme Court overturned the trial court's decision, ruling that HIPAA may inform the negligence standard of care in certain circ*mstances. The court recognized that HIPAA does not grant a private right of action, but also concluded that state causes of action are not preempted solely because they impose liability over and above that authorized by federal law. The court stated that allowing private individuals to bring negligence claims in state courts supports HIPAA's goals by establishing another disincentive to wrongfully disclose a patient's health care record.

The court further ruled that HIPAA may be used to inform the standard of care, to the extent that HIPAA has become common practice for Connecticut health care providers. According to the court, its ruling is consistent with the general rule allowing courts to consider statutes and regulations in determining the applicable standard of care in negligence cases.

Importantly, the court pointed out that state court pretrial practices must be HIPAA compliant. The court referenced a 2007 Connecticut superior court case in which the court concluded that submitting medical records to a court, even if under seal, is a disclosure under HIPAA. The superior court further concluded that even if a state statute allows the disclosure of health information in response to a subpoena, a health care provider must still comply with HIPAA's more stringent provisions.

What the Court Didn't Say

Despite its noteworthy rulings, the court declined to address whether the Avery Center actually violated HIPAA, citing the undeveloped factual record. It is important to note, however, that HIPAA covered entities (and individuals acting on behalf of covered entities) may not disclose protected health information in response to a subpoena in connection with a judicial or administrative proceeding unless one of the following conditions are satisfied:

  1. The party seeking the information or covered entity demonstrates that reasonable efforts have been made to ensure that the individual who is the subject of the requested protected health information has been given notice of the request. The party or covered entity must show that (a) it made a good faith attempt to provide written notice to the individual (or, if the individual's location is unknown, to mail a notice to the individual's last known address); (b) the notice included sufficient information about the litigation or proceeding in which the protected health information is requested to permit the individual to raise an objection to the court or administrative tribunal; and (c) the time for the individual to raise objections to the court or administrative tribunal has elapsed, and no objections were filed or all objections filed by the individual have been resolved by the court or the administrative tribunal and the disclosures being sought are consistent with such resolution.
  2. The party seeking the information or covered entity demonstrates that reasonable efforts have been made to secure a qualified protective order. The party or covered entity must provide a written statement and accompanying documentation demonstrating that (a) the parties to the dispute giving rise to the request for information have agreed to a qualified protective order and have presented it to the court or administrative tribunal with jurisdiction over the dispute, or (b) the party or covered entity has requested a qualified protective order from the court or administrative tribunal.
  3. The subpoena is accompanied by a court or administrative tribunal order that compels disclosure.

Covered entities must also comply with HIPAA's minimum necessary standard, which requires that disclosure of protected health information be limited to only the minimum amount necessary to accomplish the intended purpose of the disclosure.

In addition, even if the HIPAA requirements are met, other federal and state laws may be applicable. For example, federal and state laws impose more restrictive standards on the disclosure of certain sensitive information, such as mental health information or certain substance abuse treatment information. Because the laws regarding the disclosure of health information are complex, involving overlapping and even seemingly contradictory requirements, it is essential to have clear policies and procedures in place to ensure compliance. Instead of dealing with these requests on an ad hoc basis, organizations would be well-served to have a well thought out approach planned in advance.

Implications of the Decision

Byrne has spurred much speculation that courts will now be inundated with state negligence claims alleging HIPAA violations. Some even predict that the case may lead to a proliferation of class actions based on HIPAA violations. The Connecticut Supreme Court now joins some other courts that have already similarly ruled that state-based negligence claims involving breaches of protected health information are not preempted by HIPAA. Just last year, a jury in Indiana awarded a $1.44 million verdict against Walgreens for mishandling a customer's protected health information in a manner prohibited by HIPAA. In that case, a Walgreens pharmacist inappropriately accessed the customer's prescription record. The pharmacist then disclosed the information to her husband, with whom the customer allegedly had a relationship. The court allowed the plaintiff to use HIPAA as the standard of care to prove that Walgreens had acted negligently.

While Byrne may open the door to HIPAA-based negligence claims, there are other elements that must be alleged and proved in order for these claims to be successful. For example, negligence claims require proof of damages, which may be a difficult hurdle to surmount in cases alleging a privacy breach depending on the factual circ*mstances. Moreover, the court in Byrne did not address the underlying question of whether Connecticut's common law provides a remedy for a health care provider's breach of its duty of confidentiality in the course of complying with a subpoena.

Although the Connecticut Supreme Court's holding permitting the use of HIPAA as the standard of care was limited to negligence actions, the court laid the groundwork for the use of HIPAA in other types of claims as well, such as claims under the Connecticut Unfair Trade Practices Act (CUTPA). For example, the court noted that the trial court relied on Fisher v. Yale University, No. X10NNHCV044003207S, 2006 WL 1075035 (Conn. Super. Ct. Apr. 3, 2006). The Fisher court ruled that HIPAA cannot be used to allege a claim under CUTPA. In overturning the trial court's decision, the court left open the question whether a HIPAA violation now may be used to support a CUTPA claim. However, a successful CUTPA claim requires the plaintiff to allege and prove different elements than those required for a negligence claim.

Insurance companies and insureds should similarly consider the impact of the Byrne holding as it relates to covered occurrences or intended exclusions under liability policies. Insurers and insureds will sometimes agree to exclude claims from coverage that result from alleged or actual HIPAA violations. Those exclusions should now be reviewed. For example, if the intent is to exclude only causes of action brought pursuant to HIPAA, then the exclusion should say so expressly. But, if the intent is broader than that, and the parties intend to exclude all causes of action that rely on HIPAA as the standard of care for negligence actions, then the insurance policy wording may need to be adjusted to exclude all claims that relate to or allege breaches of HIPAA standard without regard to whether the plaintiff is a government agency or a private plaintiff. Insurers and insureds would be wise to review the specific wording of their policies and any HIPAA exclusion provisions in light of Byrne's distinction between causes of action brought under HIPAA and those brought as negligence actions alleging violations of the standard of care established by HIPAA.

Regardless of the scope of the potential implications of Byrne, those obligated to comply with HIPAA should ensure that they are fully HIPAA compliant. In particular, they should review their processes for responding to third-party subpoenas and change them as necessary to ensure compliance in the wake of the decision. Aside from the heightened risk of private lawsuits that may result from Byrne, HIPAA enforcement from both federal and state agencies has risen exponentially. Enforcement action is more frequent and settlement amounts are climbing ever higher. The federal government has also begun its second round of audits of HIPAA-covered entities and is expected to begin auditing business associates in 2015. Those obligated to comply with HIPAA must complete and document inventories and assessments in connection with the protected health information that they receive, access, maintain or transmit; develop and implement HIPAA-compliant policies and procedures; train workforce members; and enter into HIPAA business associate agreements with covered entities and other subcontractors, as applicable.

Wiggin and Dana regularly counsels state, national and international clients on compliance with HIPAA and other federal privacy and security requirements. We advise clients in the development of privacy and data security policies and procedures, and help with implementation and internal auditing. We assist clients in preventing and responding to data mismanagement and data breaches, including implementing breach notification, mitigation, and corrective action strategies. We also handle litigation and state attorney general and federal investigations of alleged data breaches.

[1] Byrne also sued the Avery Center for breach of contract and negligent misrepresentation alleging that the Center violated representations in its privacy policy. The trial court did not dismiss these claims.


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December 19, 2014 Advisory

David L. Hall

Following a year and a half of secret negotiations and a Cold War-style prisoner swap, President Obama announced yesterday that he will begin to normalize several aspects of relations with Cuba. Before you light up a few Cuban cigars to celebrate the opening of a new market only 90 miles from Miami, however, it is essential to monitor the implications for international trade, finance, and travel. The President’s speech yesterday was a statement of intent; his ability to alter existing law regarding relations with Cuba is limited, and it will likely take weeks and months to clarify the new rules of engagement.

Embargo Restrictions Will be Eased

The President announced that the U.S. will open an embassy in Havana and will ease — but not eliminate — certain restrictions in place under the Cuban embargo. The Cuban embargo is based on a patchwork of statutes and regulations. The most important of these is the Cuban Assets Control Regulations (31 CFR Part 515), issued in 1963 under the Trading with the Enemy Act (12 USC §§ 95a-95b, and 50 USC App. §§ 1-44). The Trading with the Enemy Act confers certain powers on the President to restrict trade with designated countries; the President generally administers those powers through the Treasury Department’s Office of Foreign Assets Control (“OFAC”). Specifically, President Obama announced that the U.S. will ease restrictions on family remittances and permit authorized travelers to Cuba to return with goods totaling less than $400, including alcohol and tobacco. In addition, certain banking restrictions will be eased; travelers to Cuba will be permitted to use debit and credit cards in Cuba, and U.S. financial institutions will be permitted to open accounts with Cuban banks. Exports to Cuba’s private sector will be permitted, including telecommunications equipment and infrastructure services, household goods, agricultural commodities, and equipment for small businesses and agriculture. Finally, U.S.-owned or controlled entities in third world countries will generally be granted licenses to provide services to, and engage in, financial transactions with Cuban individuals in third world countries. None of these changes, however, will take effect until OFAC issues new regulations in the coming weeks. In addition, the Commerce Department will also update the Export Administration Regulations to take into account the policy changes. Questions for certain industries, however, remain unanswered. Will the U.S. oil and gas industry be able to participate in Cuba’s offshore oil industry? As travel restrictions to Cuba are eased, what will be the ability of the U.S. hospitality industry to participate in developing Cuba’s tourist infrastructure?

Embargo to Remain in Place

President Obama acknowledged that the Cuban embargo will remain in place and called for discussions with Congress about lifting the embargo. As a result, significant restrictions on trade with Cuba will likely remain, such as the general prohibition on the export of military-related defense articles and services, even as the President directed the State Department to review Cuba’s status as a designated state sponsor of terrorism. Similarly, restrictions on the ability to engage in transactions with the government of Cuba will likely remain and could be a major impediment to any large-scale transaction or infrastructure improvement in a country with a very limited private sector. Finally, there will be questions about the ability of a Republican-controlled Congress to derail the President’s initiatives after Congress returns in January.

As events unfold and the Cuban embargo changes in the coming weeks, companies and individuals seeking to broaden their footprint in Cuba should consult with counsel before proceeding.


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January 12, 2015 Advisory

Gregory S. Rosenblatt, Jonathan D. Hall, Michael J. Kasdan, Joseph M. Casino, Abraham Kasdan, Sapna W. Palla


There were a number of notable developments in patent case law in 2014. Key decisions from the Federal Circuit and Supreme Court tackled a variety of key issues, including patent eligibility of software and business methods, standards for induced infringement when multiple actors are involved, the burden of proof in declaratory judgment cases, the continuing development of inequitable conduct jurisprudence, the standard for indefiniteness, the standard for awarding attorneys’ fees, laches, and guidance for damages, particularly for standard essential patents.

By the end of 2014, we also concluded two years of operation of the new statutory framework provided by the America Invents Act (AIA), which introduced new post-grant procedures for challenging the validity of patents at the U.S. Patent Office. As discussed further below, inter partes review and the covered business method review have become potent weapons against patent owners.

In the new landscape, one in which the eligibility – and hence validity – of many software and business method patents has been thrown into question by the Supreme Court’s Alice case, and one in which challenging the validity of patents under the AIA has proven quite successful, patent owners would be wise to review their existing portfolios and prosecution strategies and develop strategies to address these changes.

Post-Grant Proceedings

In addition to moving the United States from a first-to-invent to a first-inventor-to-file patent country, the 2012 America Invents Act (AIA) introduced new trial-like procedures that permit third parties to challenge the validity of issued patents in the U.S. Patent Office. The former inter partes re-examination procedure was replaced by inter partes review (IPR), post-grant review (PGR), and covered business method review (CBM) procedures before the newly formed Patent Trial and Appeal Board (PTAB). While patent infringement claims are still adjudicated in the courts, these new post-grant proceedings provide an alternative avenue for patent holders and challengers to battle over a patent’s validity in the Patent Office without resorting to traditional litigation in the courts.
Now two years since their inception, these post-grant proceedings are proving to be incredibly popular. Initial USPTO projections had forecast about 420 petitions per year seeking to initiate these new proceedings. However, about 600 petitions were filed in the first year since these proceedings became available, and nearly 1,900 petitions were filed in the second. Post-grant proceedings are particularly popular in the electrical/computer arts, with over 60% of petition filings occurring in this technology area.

For a comprehensive look at current and future issues related to Post-Grant Proceedings, please see our September 2014 articles in IPLAW360, available at the following links:

  • Lessons From 2 Years of AIA Post-Grant Proceedings

  • Trends From 2 Years of AIA Post-Grant Proceedings

Patent-Eligible Subject Matter

In Alice Corp. Pty. Ltd. v. CLS Bank Int’l, the Supreme Court issued a long-awaited and unanimous decision on patent eligible subject matter, holding that claims directed to implementing abstract ideas on a generic computer, without further limitations, are not patent eligible.

By way of background, courts have historically created three judicial exceptions to what otherwise is a broad statutory definition of subject matter that is eligible for patent protection (see, 35 U.S.C. §101). The Alice decision sets forth a 2-part test for determining if a patent claim is directed to eligible subject matter. First, it must be determined if the claim is directed to one of these three judicially created exceptions (e.g., an abstract idea). Second, if the claim is directed to one of these three categories, it must be determined if the claim additionally recites an “inventive concept” that covers something more specific than a law of nature, a natural phenomenon, or an abstract idea. Unless the claim recites such additional inventive concept, the claim is not eligible for patent protection.

The Alice decision has resulted in drastic changes to the eligibility of software and business method patents. Post Alice, the Federal Circuit and district courts have been invalidating many software and business method patents based on their interpretation of the Supreme Court’s Alice decision. For example, in Ultramercial, Inc. v. Hulu, LLC, the Federal Circuit concluded that the patent at issue, a software business method patent directed to viewing an advertisem*nt in exchange for access to copyrighted media, did not claim patent-eligible subject matter. The claims were not patent eligible because they simply instructed one to implement an abstract idea using routine, conventional computer activity.

However, software and business methods may still be patent eligible, if properly claimed. The Alice Court was careful to point out that a claim is not necessarily ineligible for patent protection simply because an abstract idea is involved. Patent claims, including an abstract idea, will skew more towards eligibility if they require specific implementations that do not prevent others from practicing the underlying abstract idea.

For example, in DDR Holdings, LLC v., L.P., the Federal Circuit affirmed the district court’s ruling that a patent claim directed to a system for retaining visitors on a website was patent eligible. The Federal Circuit concluded that the claimed system constituted patent eligible subject matter because it provided a new solution to a problem specifically arising in the realm of computer networks.

For its part, the United States Patent and Trademark Office (USPTO) has issued a new set of guidelines to help its Examiners properly apply the Alice test to patent claims, including abstract ideas. The Guidelines include examples of patent eligible and non-eligible claims. There is likely to be a teething period as Examiners adjust their examination process to implement these new guidelines.

As illustrated by the seemingly contradictory Federal Circuit decisions above, the line between what is and is not patent eligible subject matter remains unclear. It was clearly not the Supreme Court’s intent in Alice to eliminate software and business method patents. However, until case law further clarifies the boundaries of what constitutes patent eligible subject matter, patent applicants and patent holders of software and business method patents will face challenges in obtaining and enforcing patent rights to their inventions.

For additional information on the implications of the Alice decision and some practice tips, please see our related article: Patenting Business Methods and Software in the U.S.

FRAND / Standards-Essential Patents

While technical standards advantageously lead to cost savings for industry and provide for interoperability of many products, patented features that are covered by an industry standard can provide an unfair competitive advantage to the patent holders by requiring industry members to license those patents. Two particular concerns regarding standards-essential patents are royalty stacking (the need to license multiple patents to comply with a standard) and patent hold-up (demanding excessive royalties once companies sign on to a certain standard). To level the playing field, standards setting organizations typically require their members to license their standards-essential patents on fair, reasonable, and nondiscriminatory (also known as “FRAND”) terms.

The question of how to properly calculate damages in infringement cases involving patents subject to a FRAND obligation has been a subject of ongoing debate. This year, the Federal Circuit’s decision in Ericsson, Inc. v. D-Link Systems, Inc. provided significant guidance on this issue. Typically, a court instructs the jury in a patent infringement case on the “Georgia-Pacific factors,” a set of 15 factors that are weighed together to arrive at a reasonable royalty to be paid by the infringer. The Ericsson decision, however, noted that in cases involving FRAND patents, many of the Georgia-Pacific factors may not be relevant or may even be contrary to the FRAND obligation. The Federal Circuit held that district courts must consider the patent holder’s actual FRAND obligation and must specifically instruct the jury accordingly as to the factors it should consider. The Federal Circuit also ruled that awarded damages should only be based on the value added to the standard by the patented feature, apportioned to all other features required by the standard and should not be premised on the overall value of adopting the standard.


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January 8, 2015 Advisory

On January 6, 2015, the Financial Industry Regulatory Authority (“FINRA”) released its 2015 Regulatory and Examinations Priorities Letter highlighting a number of compliance areas that FINRA examiners will focus on in the coming year. According to FINRA’s 15-page letter, examiners will carefully scrutinize the sales practices of certain complex products, financial and operational priorities such as cybersecurity, and market integrity matters. Below is a brief summary of some of the key exam priorities raised in the 2015 letter. A copy of FINRA’s letter with all of the exam priorities is available on FINRA’s website.


Sale and Supervision of Complex Products

FINRA examiners will focus on the sales practices in alternative mutual funds (or “liquid alts”), exchange-traded products tracking alternatively weighted indices, and securities-backed lines of credit. Some of the concerns FINRA has raised with these products include how they are marketed, whether firms are accurately and fairly describing how the products work, and whether firms and their representatives understand how they will respond to various market conditions. Other products that FINRA will be paying close attention to include interest rate-sensitive fixed-income securities, variable annuities, non-traded REITs, structured retail products, and floating-rate bank loan funds.

New Supervision Rules

FINRA’s new supervision rules (FINRA Rules 3110, 3120, 3150 and 3170) became effective on December 1, 2014. Those rules modify or impose new obligations with respect to firms’ supervisory systems, WSPs, internal inspections, and transaction reviews and investigations. Examiners will look to see how firms are addressing the new rules and that the new requirements of the rules are being implemented properly.

IRA Rollovers and other “Wealth Events”

FINRA will focus on how firms handle “wealth events” in investors’ lives, such as inheritances, life insurance payouts, and IRA rollovers. The general compliance areas that examiners will scrutinize in connection with wealth events include supervisory, suitability, and disclosure obligations.


FINRA will focus on Cash Management Accounts (CMAs) and, for the second year in a row, Delivery Versus Payment/Receipt Versus Payment (DVP/RVP) accounts. FINRA will review, among other things, the adequacy of a firm’s surveillance system and the processes to identify red flags with respect to transactions in these types of accounts.

Other Sales Practices Priorities

FINRA also noted concerns with sales practices in the following areas:

  • Excessive Trading and Concentration Controls;
  • Private Placements;
  • High-Risk and Recidivist Brokers;
  • Sales Charge Discounts and Waivers;
  • Senior Investors; and
  • Municipal Advisors and Securities.



Examiners will review firms’ approaches to cybersecurity risk management, including their governance structures and processes for conducting risk assessments, and addressing the output of those assessments. FINRA’s letter also indicates that FINRA plans to release the results of its 2014 cybersecurity sweep in early 2015.

Timely Reporting of Disclosable Information

FINRA noted that it had found a number of instances where firms are failing to report disclosable information (e.g., regulatory actions, complaints, bankruptcy filings, liens, judgments) or are failing to report such information in a timely manner. The letter also reminded firms of amended Rule 3110, which becomes effective July 1, 2015, requiring firms to perform public records checks to verify the accuracy of representative’s Form U4s.

Other Financial and Operational Priorities

FINRA noted concerns with financial and operations controls in the following areas:

  • Funding and Liquidity: Valuing Non-High-Quality Liquid Assets;
  • Sales to Customers Involving Tax-Exempt or Federal Deposit Insurance Corporation;
  • (FDIC)-Insured Products; and
  • Outsourcing.


Abusive Algorithms

FINRA’s letter referred to abusive algorithmic trading and deficient supervision for manipulation in this area as one of the most significant risks to market integrity. As a result, examiners will continue their recent efforts in assessing whether firms’ testing and controls relating to algorithmic trading strategies are adequate.

Order Routing Practices, Best Execution and Disclosure

FINRA will continue to examine firms’ order-routing and best execution practices, and noted that it is still in the process of conducting its order routing sweep launched in 2014 focusing on routing decisions and whether such decisions were impacted by rebates. FINRA also noted that it is focusing on best execution failures and other trading issues associated with option orders and fixed-income securities.

Other Market Integrity Priorities

FINRA noted concerns with the following market integrity issues:

  • Supervision and Governance Surrounding Trading Technology;
  • Cross-Market and Cross-Product Manipulation;
  • Market Access;
  • Audit Trail Integrity.

FINRA’s letter identifies five “recurring challenges” that examiners have encountered over the years, such as firms failing to place customers’ interests first and failing to create a culture of compliance. According to FINRA, properly addressing these broad challenge areas should enable firm’s to get ahead of many of the more specific concerns raised in the 2015 letter.

Please feel free to contact us if you have any questions regarding FINRA’s 2015 Regulatory and Examinations Priorities Letter or any related matter.


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January 8, 2015 Advisory

Robert S. Burstein

On July 2, 2014, the Federal Trade Commission (“FTC”) issued Amended Franchise Rule FAQ 38. [1] FAQ 38 has not received much attention, perhaps due to the fact that the FTC’s website for posting FAQs has recently changed. In any event, FAQ 38 attempts to give extra-territorial effect to one state regulator’s comments on a single issue, an Item 19 financial performance representation (formerly known as an earnings claim) (“FPR”), by singling out a regulator’s comments concerning Item 19 FPRs and admonishing that the changes requested by the regulator (1) should be adopted, and (2) should be incorporated in all versions of the franchisor’s franchise disclosure document (“FDD”) and used in all states. The threatened consequences for not using the single regulator’s required FPR in all states (or for withdrawing the state application to avoid making the requested changes), is that it will call into question whether the FPR meets the requirements of the FTC Franchise Rule, and particularly whether the franchisor has written substantiation demonstrating that the FRP has a reasonable factual basis. FAQ 38 concludes by backtracking a little bit by first acknowledging that whether or not a franchisor uses the same FPR in each state will not really change the franchisor’s burden of substantiating its FPR, but repeating a threat that failing to follow a regulator’s direction on the FPR may expose the franchisor to “the risk of heightened scrutiny by federal or state franchise law enforcers.”

Why did the FTC issue FAQ 38, and what might it signal for the future? One answer could be that the FTC and the state regulators are trying to reinforce the authority of the state examiners, and perhaps, to deputize certain more aggressive examiners as the leading enforcers and interpreters of the FTC Franchise Rule. A related answer could be that the FTC and state regulators are also trying to eliminate the opportunity for franchisors to disagree with a particular state examiner’s comments by maintaining a separate FDD for use in the state making the disputed comments in order to get the FDD registered in the state, and go about their business with their original language in other states. Because FPRs are considered material (if made) and easy to isolate in the FDD, the FTC could be starting with Item 19, but could expand this concept and in the future require that a broader scope of state regulators’ comments should be adopted nationwide.

The opening statement in FAQ 38 that ordinarily a franchisor should incorporate revisions made to the FDD in response to an examiner’s comments and adopt those revisions for use everywhere is at first blush not controversial. Many may go so far as to consider such adoption to be a best practice. After all, examiners often make constructive comments and it is wise to take advantage of their review and adopt the revisions universally in all versions of the FDD. That said, we see potential flaws in FAQ 38.

Examiners are not always in agreement concerning their comments, and it is possible to receive inconsistent or conflicting comments from different state examiners. While often state examiners will cooperate and help resolve conflicts between their comments and reach a common understanding with the franchisor, state examiners are not required to agree with each other and may maintain their separate views or enforce their differing state policies.

In our experience, comments on the Item 19 FPR frequently have more to do with format or the presentation of information and disclaimers and do not often go to the issue of whether the franchisor has substantiation for the FPR. For example, Maryland required that one FPR contain separate charts of performance data for company-owned units and franchisee-owned units and could not combine data on both types of units in one chart, even though all of the other states accepted the same FPR charts combining company-owned and franchisee-owned units. Maryland examiners have also been aggressive in requesting certain language be deleted because they deem the language to be a disclaimer. FAQ 38 requires that a franchisor adopt Maryland’s revisions for use in all states. But the changes Maryland frequently requests to Item 19 arguably do not go to whether the franchisor has a reasonable factual basis for its FPR, which is the rationale the FTC uses in FAQ 38 for trying to mandate that franchisors must adopt one state’s comments on the FPR in all states. If an examiner’s comment actually concerns the issue of whether the franchisor has substantiation for the FPR, it would appear to make sense that the comment should be addressed for all states. But FAQ 38’s broad characterization that all comments concerning the FPR must be adhered to for all states because they question the factual basis of the FPR seems conclusory and overbroad.

Finally, what is the logistical impact of FAQ 38 on franchisors? A material amendment to the FDD requires that the franchisor file an amendment in a registration state (unless exempt or a filing is not otherwise required by the state). Typically, a franchisor’s responses to state examiners’ comments in the registration or renewal process are considered not to be material, and franchisors are encouraged to file a copy of the final FDD resulting from all state comments when the process has concluded, as a courtesy, but not to file a formal amendment (with the attendant fees and forms). By admonishing that all comments to Item 19 must be adopted in all states because they purport to go to the issue of whether the franchisor has substantiation for the FPR, FAQ 38 could be read to suggest that the revisions to Item 19 are material, and would therefore require a formal amendment with the registration states, where applicable. This interpretation would be an expensive and time-consuming impact of FAQ 38, delaying resumption of sales in the affected registration states while the new amendment, most likely a post-effective amendment because these other states may have already approved the FDD, must be reviewed and declared effective.

FAQ 38 was issued quietly and has received no fanfare in six months. Nevertheless, we believe FAQ 38 may be a signal of even greater state cooperation in terms of enforcement of each other’s FDD comments, and may cause greater expense and delays to franchisors in registering, renewing or amending their FDD when comments on Item 19 are issued.


38. If a franchisor is unable to register a franchise offering in a state with a franchise registration law without removing or altering a Financial Performance Representation (“FPR”) in Item 19, may the franchisor use the unaltered FPR in the Franchise Disclosure Document (“FDD”) it delivers to potential purchasers in other states?

Answer: If a franchisor revises its FDD at the request or direction of one registration state, it ordinarily should incorporate the same revisions in the FDDs it uses in other registration and non-registration states to ensure that its disclosures are complete and accurate. In the case of an FPR in Item 19 questioned by one registration state, a failure to make any resulting voluntary or involuntary changes to the FPR in all other states, or abandonment or withdrawal of the registration application without making changes, will raise significant concerns about whether the FPR meets the requirements of the Franchise Rule. In particular, any such failure will call into question whether an FPR meets the requirement that a franchisor have written substantiation demonstrating that its FPR had a reasonable factual basis at the time it was made.

As always, the franchisor will bear the burden of proving that its written substantiation shows that factual information in its possession at the time it made the representation supports the FPR as it is likely to be understood by a reasonable prospective franchisee. Any failure to use the same FPR in all states will not change the franchisor’s burden, but may expose the franchisor to the risk of heightened scrutiny by federal or state franchise law enforcers.

Issued: July 2, 2014.


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January 12, 2015 Advisory

David L. Hall

Corporate officers with compliance duties, take note: you may face personal liability for your role in failing to prevent your company’s violations of federal law. This new reality comes courtesy of the U.S. Department of the Treasury’s Financial Crimes Enforcement Network’s (“FinCEN”) unprecedented assessment, on December 18, 2014, of a $1,000,000 penalty against Thomas E. Haider, the former chief compliance officer (“CCO”) of MoneyGram, a global money services business. On the same day, U.S. Attorney for the Southern District of New York, Preet Bharara, filed a civil complaint against Mr. Haider in the district court seeking an order to enforce the FinCEN penalty and enjoin Mr. Haider from participating in the conduct of any financial institution for “a term of years – to be determined at trial – sufficient to prevent harm to the public.”

The claims against Mr. Haider stem from the Justice Department’s earlier case against Mr. Haider’s former employer, MoneyGram. In November 2012, MoneyGram, the world’s second-largest money transfer company, agreed to forfeit $100 million and admitted it aided and abetted wire fraud and failed to maintain an effective anti-money laundering program in violation of the Bank Secrecy Act (“BSA”).

In its penalty assessment against Mr. Haider, FinCEN stated it had determined that he had willfully violated the BSA by failing to ensure that MoneyGram: (1) implemented and maintained an effective anti-money laundering (“AML”) program, and (2) filed timely suspicious activity reports (“SARs”) with law enforcement when it knew, suspected, or had reason to suspect that third parties were using its money transfer service to facilitate criminal activity. FinCEN further stated that, as a result of Mr. Haider’s AML failures, agents and outlets that MoneyGram personnel knew or suspected were involved in fraud and/or money laundering were allowed to continue to use MoneyGram’s money transfer system to facilitate their fraudulent schemes.

Under the BSA and its implementing regulations, individuals responsible for a company’s failure to implement and maintain an effective AML program are liable for a civil penalty of $25,000 for each day that the company lacks an effective AML program. Similarly, individuals responsible for a company’s failure to file required SARs are liable for a civil penalty of no less than $25,000 (and up to $100,000) for each instance in which the company fails to file a required SAR. See 31 U.S.C.§ 5321(a)(1).

The seven-figure penalty against Mr. Haider emphatically punctuates the growing trend in the direction of increased individual liability for BSA violations and an aggressive use of the BSA’s enforcement mechanisms.[1] For instance, in 2013, Democrats in the U.S. House of Representatives introduced the Holding Individuals Accountable and Deterring Money Laundering Act, to give financial regulators enhanced civil powers to hold executives accountable for misconduct on their watch. That bill is currently in a Congressional subcommittee. FinCEN director Jennifer Shasky Calvery has publicly announced her agency’s intention to hold individuals liable for their roles in a company’s AML failures.[2] The $1,000,000 fine against Mr. Haider should remove all doubt in this regard.[3]

FinCEN’s enforcement action against Mr. Haider raises serious and immediate questions for all officers responsible for BSA compliance programs and for those individuals considering such a position. Is the company’s AML program adequate? What is the structure of the company’s compliance program? Who designed the program? Who is responsible for implementation? Might company shareholders have a cause of action against CCOs in light of FinCEN penalties? Will Directors & Officers liability insurance cover a FinCEN monetary penalty?

Persons potentially affected by FinCEN’s trend toward individual liability would do well to consult with counsel on these questions.

[1] The trend towards individual liability for CCOs is discussed in The Rise of ‘Failure to Prevent’ Crimes and CCO Liability by Wiggin and Dana attorneys David Ring and Claire Coleman in the New York Law Journal Compliance Special Section, October 27, 2014, which is available here.

[2] Remarks of FinCEN Director Jennifer Shasky Calvery at Securities Industry and Financial Markets Association Anti-Money Laundering and Financial Crimes Conference (January 30, 2014)

[3] FinCEN is not the only regulator in the financial industry increasing enforcement against individuals for their role in a company’s malfeasance. One very recent example is the New York State Department of Financial Services’ settlement, on December 22, 2014, with Bank Leumi over that bank’s role in helping its clients evade U.S. taxes. In addition to a $130 million fine levied against the bank, the settlement requires Bank Leumi to terminate a bank manager and bar another employee from compliance duties.


  • advisory-former-compliance-office-assessed-million-dollar-penalty-jan-2015.pdf

Publications Archive - Page 153 of 293 - Wiggin and Dana LLP — Attorneys At Law (6)

January 16, 2015 Advisory

On January 12, 2015, the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) released its Examination Priorities for 2015 (available here) outlining the issues that it will focus on this year in examining investment advisers, broker-dealers and other financial industry participants. This year’s exam priorities are broken down into three thematic areas: (1) protecting retail investors and investors saving for retirement, (2) market-wide risk areas (such as cybersecurity), and (3) using data analytics to identify illegal activity. These themes, as well as the specific compliance/legal issues identified by OCIE as falling under these themes, are outlined below.

Protecting Retail Investors and Investors Saving for Retirement

OCIE’s top priority for 2015 appears to be protecting retail investors. Not surprisingly, this theme is echoed in FINRA’s 2015 Examination Priorities Letter for broker-dealers, released last week (click here for our update on FINRA’s exam priorities). According to the letter, OCIE is planning various examination initiatives for 2015 to assess the potential risk to retail investors arising from the increase in popularity of products, services and investment strategies that have traditionally only been accessible to institutional investors, such as private funds, illiquid investments, and structured products intended to generate higher yields in a low-interest rate environment. The specific products and associated issues highlighted by OCIE are discussed below.

Fee Selection and Reverse Churning

OCIE’s examination of fees will look at investment advisers (and dual-registrants) that offer a variety of fee structures in addition to fees based on assets under management, such as hourly fees, performance-based fees, wrap fees, and unified fees, and scrutinize whether such arrangements are in the best interest of the client at the inception of the arrangement and thereafter.

Sales Practices & Suitability

OCIE will review whether investment advisers and broker-dealers are improperly recommending the movement of retirement assets from employer-sponsored defined contribution plans into complex products that may pose greater risks and/or charge higher fees. OCIE will also examine disclosures in this area.

Branch Offices

OCIE will scrutinize the supervision of representatives in branch offices. Additionally, OCIE will focus on branch offices on a stand-alone basis, using data analytics to identify branches that may be deviating from compliance practices of the firm’s home office.

Alternative Funds (“Liquid Alts”)

In conjunction with its industry sweep launched in 2014, OCIE will continue to assess alternative mutual funds (i.e., registered funds that employ hedge-fund-like strategies) in 2015. OCIE’s examinations will emphasize: (i) leverage, liquidity, and valuation policies and practices; (ii) factors relevant to the adequacy of the funds’ internal controls, including staffing, funding, and empowerment of boards, compliance personnel, and back-offices; and (iii) the manner in which funds are marketed to investors.

Fixed-Income Funds

OCIE will be reviewing whether registered funds with significant exposure to interest rate increases have implemented policies, procedures and controls sufficient to ensure that their funds’ disclosures are not misleading and that their investments and liquidity profiles are consistent with those disclosures. Advisers to fixed-income funds should review the SEC’s Division of Investment Management’s 2014 IM Guidance, which sets forth several suggested fixed income securities risk management practices (available by clicking here).

Market-Wide Risks

In terms of market-wide risk areas, OCIE will be assessing the following issues, among others:


OCIE announced that it will continue to examine investment advisers’ and broker-dealers’ cybersecurity compliance and controls and will expand these examinations to include transfer agents. Firms that are currently assessing their cybersecurity efforts should be familiar with OCIE’s 2014 cybersecurity risk alert (available here) and the sample document request attached to the alert, which identifies certain cybersecurity processes and procedures that the SEC will be looking for. Additionally, firms should be looking out for the results of the SEC and FINRA’s recent cybersecurity sweeps, based on FINRA’s recent announcement that it will make its results public soon and the SEC at least suggesting that its results may be publicly available at some point.

Best Execution

OCIE will assess whether firms are prioritizing trading venues based on payments or credits for order flow in conflict with their best execution duties.

Using Data Analytics to Identify Illegal Activity

OCIE will continue to utilize its recently enhanced data analytics capabilities, including its recently developed national exam analytics tool (“NEAT”), which allows examiners to rapidly analyze voluminous trade data. Some of the activities that OCIE intends to monitor include:

Recidivist Representatives

OCIE will use analytics to identify individuals with a track record of misconduct and examine the firms that employ them.

Excessive Trading

OCIE will analyze data obtained from clearing brokers to identify and examine introducing brokers and registered reps for patterns of excessive trading.

Anti-Money Laundering (“AML”)

OCIE will continue to focus on clearing and introducing broker-dealers’ AML programs, using data to focus on firms that have not filed suspicious activity reports (“SARs”) or have filed incomplete or late SARs. Additionally, OCIE will scrutinize broker-dealers that allow customers to deposit and withdraw cash and/or provide customers direct access to the markets from higher-risk jurisdictions.

Other Initiatives

In addition, OCIE identified other examination priorities for 2015, including:

  • Fees and Expenses in Private Equity;
  • Never-Before-Examined Investment Companies;
  • Municipal Advisors;
  • Proxy Services;
  • Transfer Agents;
  • Large Firm Monitoring;
  • Clearing Agencies; and
  • Microcap Fraud.

* * * * *

Please feel free to contact us if you have any questions regarding OCIE’s 2015 examination priorities or any related matter.


  • imu-sec-releases-exam-priorities-for-2015-jan-2015.pdf

Publications Archive - Page 153 of 293 - Wiggin and Dana LLP — Attorneys At Law (7)

January 22, 2015 Advisory

Michael J. Kasdan, Joseph M. Casino, Abraham Kasdan, Sapna W. Palla

This week, the Supreme Court rejected the Federal Circuit’s long standing practice of applying a de novo review standard to district court claim construction decisions. Instead, in Teva Pharmaceuticals USA, Inc. V. Sandoz, Inc., No. 13–854 (Jan. 20, 2015), the Supreme Court ruled that factual findings made by the district court in connection with claim construction can be reversed on appeal only when they are clearly erroneous. As a result, cases where extrinsic evidence, such as expert testimony, is relied on to determine factual issues central to claim construction (including claim indefiniteness) will be more difficult to reverse on appeal.

In Teva, the district court relied on expert testimony and found that a skilled artisan would understand that the claim term “molecular weight” was limited to mean molecular weight as calculated by a particular method shown in the patent. The Federal Circuit reviewed this factual finding de novo and reversed. However, the Supreme Court held that the Federal Circuit should have applied a “clear error,” not a de novo, standard of review for such factual determinations, even though claim construction is ultimately a question of law. The Supreme Court relied on Federal Rule of Civil Procedure 52(a)(6), which states that a court of appeals “must not . . . set aside” a district court’s “[f]indings of fact” unless they are “clearly erroneous.” The Court found no convincing reason to depart from this rule in patent cases, and recognized that the complex nature of patent cases supports giving such deference to the original finder of fact:

[P]ractical considerations favor clear error review. We have previously pointed out that clear error review is ‘particularly’ important where patent law is at issue because patent law is ‘a field where so much depends upon familiarity with specific scientific problems and principles not usually contained in the general storehouse of knowledge and experience.’ Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U. S. 605, 610 (1950). A district court judge who has presided over, and listened to, the entirety of a proceeding has a comparatively greater opportunity to gain that familiarity than an appeals court judge who must read a written transcript or perhaps just those portions to which the parties have referred.

(Slip Op. at 7-8). In other words, the Supreme Court thought it important to give deference to the district court’s firsthand review of any extrinsic evidence showing what one of ordinary skill in the art would consider to be the right construction of a patent claim, as is the practice in other areas of law, including contract interpretation.

In so doing, the Supreme Court recognized that “[i]n some instances, a factual finding will play only a small role in a judge’s ultimate legal conclusion about the meaning of the patent term. But in some instances, a factual finding may be close to dispositive of the ultimate legal question of the proper meaning of the term in the context of the patent.” (Slip Op. at 13).

The Teva decision is critical for cases where the intrinsic evidence (i.e., the patent, its prosecution history and the cited prior art) may not be clear cut and where extrinsic evidence is introduced and relied upon. It will also be significant in most cases where indefiniteness is at issue, as was the case in Teva. If parties use expert witnesses to opine on factual issues or present other evidence that requires a factual determination, a district court’s decision will be harder to reverse on appeal.

Litigation strategies will have to take this new development into account. For example, the Teva decision will require more thought to be given to issues such as venue and the proclivities of the assigned judge, in cases where factual determinations will be required for claim construction.

We will continue to monitor the developing law in this area. Please let us know if you have any questions.


  • advisory-supreme-court-changes-appellate-review-standard-for-client-construction-jan-2015.pdf

Publications Archive - Page 153 of 293 - Wiggin and Dana LLP — Attorneys At Law (8)

February 3, 2015 Advisory

David L. Hall

On January 21, 2015 the U.S. House of Representatives Committee on Science, Space, and Technology’s Subcommittee on Space met to discuss UAS Research and Development (R&D). The purpose of the Subcommittee was to look into R&D developments at the Federal Aviation Administration (FAA) and National Aeronautics and Space Administration (NASA). NASA was present in conjunction with its lesser known Aeronautical function, but it was the FAA that received most of the attention, particularly regarding its slow rulemaking for Unmanned Aerial Systems (UAS).

The headline grabbing news was that a Parrot Bebop, a readily available $499 UAS, was flown not once, but twice, in the hearing room. The Chairman had quipped that the Bebop should fly over his head, but a minor crash changed his mind and provided an educational moment regarding the safety considerations one must take when using a UAS. The FAA did not have a say in the flight since they do not regulate indoor use of UAS, but the Subcommittee was pushing the comfort level of some lawmakers with the demonstration.

The FAA was asked many times about its plans to issue a small UAS rule. The witness refused to give even a target date, saying only that the FAA wanted to issue comprehensive and safe regulations. Many in the UAS industry believe this presents a “chicken and egg” situation because the full range of safety issues can’t be addressed until UAS start flying; that the FAA should allow small UAS to fly, since they pose a low risk to safety, and learn from that experience. In order to strengthen this argument, some UAS manufacturers are equipping their products with a feature that allows flight data to be uploaded to a central repository. This data can then be analyzed by researchers and used to propose flight rules.

Representatives from the UAS industry also pointed out that the concerns with small UAS are negligible compared to larger UAS or manned aircraft. The biggest safety concern with small UAS is a mid-air collision with a manned aircraft. However, airplanes are designed to withstand a bird strike, and UAS weighing less than 2 kg would be within these design standards. Regulations for aircraft less than 2 kg have been implemented in other countries to successfully integrate small UAS into the their airspace and to use lessons from that integration to refine rules.

The six statutorily required test sites approved by the FAA received significant attention. They were selected by the FAA because of their varying characteristics and, in conjunction with industry, will conduct research into the requirements necessary to integrate UAS into the National Airspace System (“NAS”). Industry witnesses were concerned because the sites are underutilized, expensive to use, and difficult to access. The sponsoring states pay for the sites and are reimbursed through user fees, but since there are so few users, the cost to use them are high. The industry has noted this is a large reason why R&D is moving to Canada and Mexico.

The sites lack a defined mission, as discussed in “FAA Testifies To Congress: More UAS Delays” (12/16/2014). The FAA cannot directly task the test sites without funding the request due to Federal procurement regulations, but last fall the FAA sent the sites a list of topics they would like researched. Regardless, without funding the sites are reliant on non-federal users for work-product. The industry believes that the test site system poses serious barriers of entry to smaller businesses and does not provide comprehensive data for integrating UAS into the NAS. The industry would prefer to test UAS on a dedicated portion of company property, but receiving an Experimental Use Certificate to do so can also be a lengthy process.

The FAA summarized their progress in getting UAS into the sky. They are trying to speed up the 333 Exemption process, but noted that it is still a regulatory process that must go through multiple stages. This includes allowing for public comment, which has been utilized on every 333 Exemption issued. The FAA has two employees working full-time to facilitate approval for public entities to fly UAS through a separate process and over 700 COAs have been issued to public entities. Furthermore, two entities in Alaska have gone through the standard aircraft certification process, including commercial certification of the pilots, to inspect oil pipelines. The aircraft are operating under restricted category “type certificates.”

There are operational issues that need further R&D to be implemented on a large scale. One of the major and often discussed barriers is the sense-and-avoid requirement for aircraft. The FAA’s position is that sense-and-avoid requires a human on board the aircraft, effectively making it impossible for UAS to comply with airworthiness requirements without a waiver. NASA has been performing significant research in this area and has been working to determine how to present information obtained from onboard sensors to UAS pilots.

UAS will be a noticeable part of the economy once authorized for use in the NAS. A recent study has found that UAS markets in the U.S. are predicted to increase from $0.6 billion in 2014 to $4.8 billion in 2021. One of the Representatives from the mid-west was told that approximately 80% of UAS are expected to be used for agricultural purposes to perform dangerous pesticide operations and to otherwise optimize cultivation. On a less positive note, a UAS crashed recently outside of San Diego near the Mexican border carrying over 6 pounds of methamphetamine.


  • advisory-a-uas-on-capitol-hill-feb-2015.pdf
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